Trial intelligence / Profile preview

Rosiglitazone in HIV-Associated Hyperlipidemia

NCT00006493Phase 2

Key facts

Status: Completed
Countries: 1
Sponsor: National Center for Research Resources
Modality: Small Molecules

Drugs: rosiglitazone
Conditions: HIV-associated lipodystrophy (HALS)hyperlipidemia

Overview

Phase 2, randomised, double-blind trial in HIV-associated lipodystrophy (HALS) and hyperlipidemia comparing Rosiglitazone with Placebo (2 arms). Primary endpoint: Insulin sensitivity at 3 months. Status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Rosiglitazone
Rosiglitazone 4 mg/day
Placebo
Placebo matching Rosiglitazone

Who it enrols

HIV-positive patients with CD4 > 500, undetectable viral load, on protease inhibitors for > 3 months, with serum triglycerides > 400 mg/dl and clinical diagnosis of HIV-associated lipodystrophy. Excludes patients with type II diabetes, liver disease, or Hepatitis B/C.

Endpoints

Primary

Insulin sensitivity3 months

Secondary

Adiponectin levels3 months
Free fatty acid levels3 months
Body fat percentage3 months
Subcutaneous leg fat area3 months
Total cholesterol3 months
Serum triglycerides3 months

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